Method of using angioplasty apparatus facilitating rapid exchanges

ABSTRACT

Apparatus for introduction into the vessel of a patient comprising a guiding catheter adapted to be inserted into the vessel of the patient and a device adapted to be inserted into the guiding catheter. The device includes a flexible elongate member and a sleeve carried by the flexible elongate member near the distal extremity thereof and extending from a region near the distal extremity to a region spaced from the distal extremity of the flexible elongate element. The device also includes a guide wire adapted to extend through the sleeve so that the guide wire extends rearwardly of the sleeve extending alongside of and exteriorally of the flexible elongate element into a region near the proximal extremity of the flexible elongate element.

This is a continuation application of application Ser. No. 08/208,972which was filed on Mar. 9, 1994, now U.S. Pat. No. 5,451,2 which is adivisional of Ser. No. 08/010,458, filed Jan. 27, 1993, now U.S. Pat.No. 5,300,085, which is a continuation of Ser. No. 07/774,479, filedOct. 10, 1991, (now abandoned) which is a continuation of Ser. No.07/548,200, filed Jul. 5, 1990, now U.S. Pat. No. 5,061,273, which is acontinuation of Ser. No. 07/361,676, filed Jun. 1, 1989 (now abandoned),which is a continuation of Ser. No. 07/117,357, filed Oct. 27, 1987,(now abandoned) which is a continuation of Ser. No. 06/852,197, filedApr. 15, 1986 (now abandoned).

This invention relates to angioplasty apparatus facilitating rapidexchanges and a method for making rapid exchanges of angioplastydevices.

At the present time in practicing angioplasty, it is often necessary toexchange one dilatation catheter for another. In doing so, it has beennecessary to utilize long exchange wires having a length ofapproximately 300 centimeters which typically requires two operators toperform the procedure. During this procedure, it is necessary that theoperators communicate with each other which makes the procedure timeconsuming. In addition, since the exchange wire is so long it often isawkward to handle and for that reason may come in contact with the flooror become contaminated which necessitates removing the entire apparatusbeing utilized for the angioplasty procedure. There is therefore a needfor a new and improved angioplasty apparatus which overcomes suchdifficulties.

In general, it is an object of the present invention to provide anangioplasty apparatus and a method which facilitates rapid exchanges ofvarious types of devices.

Another object of the invention is to provide an angioplasty apparatusand method of the above character which greatly facilitates exchanges ofdilatation catheters.

Another object of the invention is to provide an angioplasty apparatusand method of the above character which can be utilized for thepositioning of flexible elongate members.

Another object of the invention is to provide an angioplasty apparatusand method of the above character which can be utilized with varioustypes of devices utilizing flexible elongate members.

Another object of the invention is to provide an angioplasty apparatusand method in which dye injection and pressure measurements can be made.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments are set forthin conjunction with the accompanying drawings.

FIG. 1 is a side elevational view of an angioplasty apparatusincorporating the present invention.

FIGS. 2A, 3A and 4A are partial cross sectional views of the shaft,transition and balloon regions of the balloon dilatation catheterutilized in the embodidment of the invention shown in FIG. 1.

FIGS. 2B, 3B and 4B are cross sectional views taken along the lines2B--2B, 3B--3B and 4B--4B of FIGS. 2A, 3A and 4A respectively.

FIGS. 5A, 6A and 7A are cross sectional views corresponding to FIGS. 2A,3A and 4A of another embodiment of a balloon dilatation catheterincorporating the present invention.

FIGS. 5B, 6B and 7B are cross sectional views taken along the lines5B--5B, 6B--6B and 7B--7B of FIGS. 5A, 6A and 7A respectively.

FIGS. 8A and 9 are cross sectional views of the transition and balloonregions of another balloon dilatation catheter incorporating the presentinvention.

FIG. 8B is a cross sectional view taken along the line 8B--8B of FIG.8A.

FIG. 10 is a side elevational view of a dedicated dye injection/pressuremeasurement catheter incorporating the present invention.

FIG. 11 is a side elevational view of a fiber optic cable incorporatingthe present invention.

FIG. 12 is a side elevational view of a dedicated dye injection/pressuremeasurement catheter incorporating the present invention and havingspecific guiding means for facilitating entering acute bends in arterialvessels.

FIG. 13 is a side elevational view of a bail out catheter incorporatingthe present invention.

FIG. 14 is a plan view of a holder utilized in connection with thepresent invention.

In general, the angioplasty apparatus of the present invention isdesigned for introduction into the vessel of a patient. It consists of aguiding catheter which is adapted to be inserted into the vessel of thepatient. It also consists of a device which is adapted to be insertedinto the guiding catheter. The device includes a flexible elongatemember, a sleeve is secured to the flexible elongate member near thedistal extremity thereof and extends from the distal extremity into aregion spaced from the distal extremity of the flexible elongate member.The device also includes a guide wire which is adapted to extend throughthe sleeve from the distal extremity of the flexible elongate element,through the sleeve and rearwardly of the sleeve alongside of andexteriorally of the flexible elongate element.

More particularly as shown in FIGS. 1-4, the angioplasty apparatus 16for facilitating rapid exchanges of dilatation catheters consists of aconventional guiding catheter 17 which is provided with a rotatablehemostatic adapter 18 mounted on a proximal end and a y or two-armconnector or adapter 19 which is mounted on the rotatable adapter 18.The y-connector 19 is provided with a knurled knob 21 which carries athreaded valve member 22 that carries an O-ring 23 which is adapted tobe urged into sealing engagement with a balloon dilatation catheter 26and a guide wire 27 extending through the y-adapter 19 and through theguiding catheter 17 as shown in FIG. 1.

The balloon dilatation catheter 26 is of a single lumen type and isprovided with a flexible elongate tubular member 29 which has a lumen 31extending therethrough. The flexible tubular member 29 can be formed ofa suitable material such as plastic. A Luer-type fitting 32 is mountedon the proximal extremity of the flexible tubular member 29 and isadapted to be connected to a syringe or other type of instrument forintroducing a radiographic contrast liquid into the flexible tubularmember 29. A balloon 33 is mounted on the distal extremity of anotherflexible tubular member 36 also is formed of a suitable material such asplastic. The distal extremity of the balloon 33 is bonded to the distalextremity of the flexible tubular member 36 to form an air-tight andliquid-tight seal with respect to the same. The balloon 33 is coaxialwith the tubular member 36 or sleeve as shown in FIG. 4B. The flexibletubular member 36 is provided with a guide wire lumen 37 through whichthe guide wire 27 carrying its flexible tip 28 can extend.

Means is provided for forming a balloon inflation lumen 41 substantiallyconcentric with the flexible tubular member 36 and extends toward thedistal extremity of the flexible tubular member 36. As can be seen fromFIGS. 3B and 4B, the balloon inflation lumen 41 is formed by a flexibletubular member 42 which can be formed integral with the balloon 33. Theflexible tubular member 42 extends into a transition region 44 whichoverlies the distal extremity of the flexible tubular member 29 so thatthe lumen 31 therein is in communication with the balloon inflationlumen 41. As can be seen particularly from FIG. 3A, the flexible tubularmember 36 makes a transition and extends out of the tubular member 42and provides an opening 43. The proximal extremity of the tubular member36 overlies the flexible tubular member 31. The guide wire 27 exitsthrough the opening 43 and extends alongside and exteriorally of theflexible tubular member 29 from the proximal extremity of the flexibletubular member 36 to the proximal extremity of the flexible tubularmember 29.

The transition region 44 should be positioned at least approximately10-15 centimeters from the distal extremity of the balloon dilatationcatheter 26. This is important for two reasons. One is that thetransition region be kept at a point where when the balloon dilatationcatheter 26 is utilized in a procedure, the transition region remains inthe guiding catheter 27 and out of the coronary artery. The spacing fromthe distal extremity of the dilatation catheter for the transitionregion is also advantageous in that it permits the person performing theprocedure to pull the balloon dilatation catheter 26 out of the guidingcatheter 17 until the transition region 44 clears the y-connector 19 sothat all of the portion of the guide wire 27 which is exterior of theballoon dilatation catheter 26 is proximal of the y-connector. Whilethis is being done, the operator can then utilize the knurled nut 21 toagain close the O-ring to form a hemostatic seal between the y-connectorand the balloon dilatation catheter to minimize the loss of blood fromthe patient.

The flexible tubular member 42 can be formed of a suitable material suchas a heat shrinkable plastic so that it can be shrunk onto the distalextremity of the flexible tubular member 29 and onto the proximalextremity of the flexible tubular member 36 to form liquid-tight andair-tight seals with respect to the same. From the construction shown itcan be seen that the guide wire 27 exits from the balloon dilatationcatheter 26 in a region which is relatively close to the distalextremity of the balloon dilatation catheter 26 and extends exteriorallyof the balloon dilatation catheter to the proximal extremity of thesame. As shown in FIG. 1, the guide wire 27 and the balloon dilatationcatheter 26 extend outwardly from the y-connector 19.

A torquer 46 of a conventional construction is secured to the guide wire27 for rotating the guide wire as hereinafter described.

Operation and use of the angioplasty apparatus shown in FIG. 1 may nowbe briefly described as follows. The guiding catheter 17 is insertedinto the coronary artery in a conventional manner. The balloondilatation catheter is prepared for insertion into the guiding catheter17 in a conventional manner. The balloon 33 can be inflated outside thebody by the use of a balloon flushing tube of the type described in U.S.Pat. No. 4,323,071 and inflated by introducing a radiopaque liquidthrough the fitting 32 into the lumen 31 and through the lumen 41 intothe balloon 33 to flush all of the air in the balloon 33 through theballoon flushing tube to fully inflate the balloon. After the balloon 33has been inflated, the balloon can be deflated by removing theradiopaque liquid from the balloon.

The guide wire 27 is then introduced into the balloon dilatationcatheter 26 by a back loading technique. Without the torquer 46 on theguide wire, the proximal extremity of the guide wire 27 is insertedbackwardly through the tip of the balloon dilatation catheter throughthe guide wire lumen 37. The guide wire is advanced rearwardly byholding the distal extremity of the balloon dilatation catheter in onehand and advancing the guide wire 27 rearwardly with the other handuntil the guide wire 27 exits through the opening 43 at the transitionregion 44 of the dilatation catheter. As soon as the guide wire hascleared the opening 43, the guide wire can be grasped by the hand andpulled rearwardly paralleling the balloon dilatation catheter 26 untilits proximal extremity is near the proximal extremity of the dilatationcatheter and so that the distal extremity of the guide wire 27 with itsflexible or floppy tip 28 protrudes at least partially from the distalextremity of the balloon dilatation catheter.

At this point in time, the O-ring 23 in the y-connector 19 is opened byoperation of the knurled knob 21. The distal extremity of the balloondilatation catheter 26 having the flexible tip protruding therefrom isthen introduced to the y-connector past the opened o-ring 23 and sliddown the guiding catheter 17. The balloon dilatation catheter 26 and theguide wire 27 are grasped between the fingers of a hand and are advancedparallel into the guiding catheter 17. This procedure is continued untila substantial portion of the balloon dilatation catheter is disposed inthe guiding catheter 17.

The torquer 46 now can be attached to the guide wire 27 near theproximal extremity of the same. The guide wire 27 is then advanced aheadof the balloon dilatation catheter until it enters the arterial vesselof the patient. The balloon dilatation catheter 26 is held stable by thefingers of the hand while the guide wire 27 is being advanced. Thepositioning of the guide wire. 27 in the desired arterial vessel can beobserved under a fluoroscope by using x-ray techniques well known tothose skilled in the art. As is well known to those skilled in the art,the torquer 46 can be utilized for rotating the guide wire 27 tofacilitate positioning of the flexible tip 28 in the desired arterialvessel so that the distal extremity of the guide wire can be advancedinto the stenosis which it is desired to open or enlarge.

As soon as the guide wire 27 is in the desired location, it can be heldstationary by two fingers of the hand and at this point in time, theballoon dilatation catheter 26 is advanced over the guide wire until thedeflated balloon 33 is across the desired lesion or stenosis. If anydifficulty is encountered by the person conducting the procedure inintroducing the balloon dilatation catheter so that the balloon 33resists crossing the lesion or stenosis, the guide wire 27 can beretracted slightly. The person then can observe under the fluoroscope tosee that the tip 28 of the guide wire is wiggling in the blood streamindicating that it is free to move in the blood stream. Then the personcan grasp both the guide wire and the dilatation catheter in one handand advance them as a unit so that they can cross the stenosis as aunit. It has been found by utilizing such a procedure, greaterpushability can be obtained in advancing the balloon dilatation catheteracross the stenosis. In other words, more force can be applied to theballoon to cause it to cross the stenosis or lesion in case the openingtherein is very small.

After the balloon 33 has crossed the stenosis or lesion, the balloon 33can be inflated in a conventional manner by introducing a radiopaquecontrast liquid through the lumen 31. After the inflation has occurredand the desired operation has been performed by enlarging the opening inthe stenosis, the balloon dilatation catheter 26 can be removed veryrapidly by the person performing the procedure by grasping the guidewire 27 by two fingers immediately proximal of the y-connector 19 afterthe torquer 46 has been removed. The balloon dilatation catheter 26 canbe removed in several seconds in comparison with the much longer timerequired for removing the balloon dilatation catheter utilizing priorart exchange wire procedures. As soon as the balloon dilatation catheter26 has been removed from the guiding catheter 17, another injection ofradiographic contrast liquid can be introduced through the guidingcatheter 17 to observe whether or not the balloon dilatation procedurewhich has been performed on the lesion or stenosis has in fact openedthe lesion or stenosis to the satisfaction of the person performing theprocedure.

If it is ascertained by the person performing the procedure thatadditional dilation of the stenosis is desired and that a larger balloonshould be inserted into the stenosis, this can be accomplished veryrapidly by selecting the desired size of balloon dilatation catheter.

As the balloon dilatation catheter 26 is being retracted out of theguiding catheter 17 and as soon as the transition region 44 has clearedthe y-adapter 19, the o-ring 23 can be tightened down to form a sealover the balloon dilatation catheter to minimize the loss of blood ofthe patient. Thereafter, if desired, the remainder of the balloondilatation catheter 26 can be removed from the guiding catheter 17 untilthe proximal extremity of the guide wire passes through the opening 43and passes through the end of the balloon dilatation catheter 26. Assoon as this has been accomplished, a new balloon dilatation cathetercan be loaded onto the guide wire in a rearward direction by introducingthe proximal extremity of the guide wire 27 into the tip of the balloondilatation catheter. As this is being done, the index finger of the handperforming the procedure can be utilized for opening the o-ring byadjusting the knurled knob 21. The guide wire 27 is grasped by thefingers of the hand and the balloon dilatation catheter 26 can beadvanced rapidly over the guide wire into the guiding catheter 17 andadvanced across the lesion in a manner hereinbefore described withrespect to the smaller balloon dilatation catheter which had beenutilized. The balloon of the new dilatation catheter can be inflated inthe same manner as hereinbefore described. If necessary even anotherexchange procedure can be readily accomplished in the same manner ashereinbefore described utilizing a still larger balloon dilatationcatheter if that turns out to be necessary.

It has been found that an exchange utilizing the present angioplastyapparatus can be, performed in less than 10 to 15 seconds whereas in thepast utilizing a prior art guide wire exchange procedure required anaverage of approximately two minutes.

After the desired amount of dilation of the stenosis or lesion has beenaccomplished, the balloon dilatation catheter 26 can be removed andthereafter, the guiding catheter 17 can be removed.

Another embodiment of an angioplasty apparatus incorporating the presentinvention is shown in FIGS. 5A and 5B, 6A and 6B and 7A and 7B in whichan additional dye/pressure lumen has been incorporated into theapparatus in order to enable an injection of a distal dye through theballoon dilatation catheter and also to enable the measurement ofpressures at the tip of the balloon dilatation catheter. Theconstruction which is utilized is very similar to that shown in theballoon dilatation catheter 26 shown in FIG. 1. The corresponding partsof the balloon dilatation catheter 26a shown in FIGS. 5-7 is verysimilar to that hereinbefore described and for that reason thecorresponding parts have been given the same corresponding numbers withletters being added to the numerals where changes are present in theparts or components. Thus the tubular member 29a, rather than having asingle lumen 31 is provided with dual lumens 31a and 31b disposed sideby side in the shaft region of the balloon dilatation catheter as shownin FIGS. 5A and 5B. In the transition region 44a, the two lumens 31a and31b are still disposed side by side with the lumen 37a for the guidewire being disposed above the lumens 31a and 31b. In the balloon region,the lumen 31a has been terminated and extends into the balloon lumen41a. At the transition region 44a, the guide wire lumen 37a inclinesdownwardly and sidewise and adjoins the lumen 31b through the distalextremity of the balloon dilatation catheter 26a. The lumen 31b extendsto the distal extremity of the balloon dilatation catheter.

The balloon dilatation catheter which is shown in FIGS. 5-7 can beutilized in the same manner as the balloon dilatation catheter shown inFIG. 1. It can be seen that the guide wire 27 extends out of the opening43a in the transition region 44a and parallels the balloon catheter toits proximal extremity. A balloon dilatation catheter of the type shownin FIGS. 5-7 can be utilized initially in an angioplasty procedure.However, it should be appreciated that if a very small opening ispresent in the stenosis or lesion, it may be desirable to utilize aballoon dilatation catheter of the type shown in FIG. 1 first because itcan be constructed with a smaller diameter than a balloon dilatationcatheter of the type shown in FIGS. 5-7 because of the additional lumenwhich is provided for dye injection and pressure measurements. After asmaller balloon dilatation catheter has been utilized, a balloondilatation catheter of the type shown in FIGS. 5-7 can be used utilizingthe exchange procedure hereinbefore described to make dye injectionand/or pressure measurements through the use of the additional lumen31b. It is particularly desirable to make such a pressure measurementbefore conclusion of the angioplasty procedure to be sure that theproper dilation of the lesion or stenosis has occurred and that there isadequate blood flow through the lesion or stenosis.

Still another embodiment of the angioplasty apparatus incorporating thepresent invention is shown in FIGS. 8A and 8B and shows the transitionregion of a balloon dilatation catheter 26b which incorporates a venttube 51 which is utilized for venting air from the balloon duringinflation of the balloon and before insertion into the patient withradiopaque liquid to ensure that all the air is exhausted from theballoon. As shown in the transition region 44b in FIG. 8A, the guidewire 27 extends through an opening 43b provided in the transition regionand extends through a flexible tubular member 36b out the end of theballoon dilatation catheter as shown in FIG. 9. A balloon filling lumen31c is provided by the flexible tubular member 29b and terminates in thetransition region 44b where it opens into the balloon filling lumen 41bthat opens into the interior of the balloon 33b. A relatively shortsleeve 52 formed of a suitable material such as plastic is also providedin the transition region 44b and as shown in FIG. 8A underlies theflexible tubular member 29b and extends from a region forward of theflexible tubular member 42b and terminates distally within the ballooninflation lumen 41 as shown in FIG. 8A.

The sleeve 52 is provided with a lumen 53 through which the vent tube 51extends. The vent tube 51 can be formed of a suitable material such asmetal and is also provided with a lumen 54 of a size so that gas canescape therethrough. The proximal extremity of the vent tube 51 isprovided with a portion 51a which is bent at right angles to the mainportion of the vent tube 51 to ensure that the vent tube will be removedfrom the balloon dilatation catheter 26b prior to insertion into theguiding catheter 17. As shown in FIG. 9, the vent tube 51 extends intothe balloon 33 into a region near the distal extremity of the same.

Operation of the balloon dilatation catheter 26b shown in FIGS. 8A, 8Band 9 may now be briefly described as follows. With the vent tube 51 inplace in the balloon dilatation catheter, radiopaque contrast liquid isintroduced through the balloon inflation lumen 31 and through theballoon inflation lumen 41b to introduce the liquid into the balloon. Asthe liquid is introduced into the balloon, any air in the balloon isdischarged through the vent tube 51. Pressure is maintained on theradiopaque contrast liquid introduced into the balloon until droplets 56of the liquid exit from the proximal extremity of the vent tube 51 whichserves to indicate that the balloon has been completely filled with theradiopaque contrast liquid and that all of the air therein has beenexhausted therefrom. As soon as this occurs, the vent tube 51 can bewithdrawn completely from the balloon dilatation catheter. The sleeve 52which carries the vent tube collapses upon withdrawal of the vent tubeand will remain collapsed to provide a valve to prevent the escape ofany additional radiopaque contrast liquid from the balloon 33b. Thesleeve 52 remains collapsed because when a high pressure is beingintroduced through the balloon inflation lumen 31c, the flexible tubularmember 29b will force collapsing of the sleeve 52. Alternatively, when anegative pressure is being applied to the balloon 33b as, for example,when the balloon is being deflated, the positive atmospheric pressure onthe exterior of the flexible tubular member 42b will again causecollapsing of the sleeve 52. Thus in effect there is provided a doublevalve system in which positive pressures on the interior will collapsethe sleeve and when there is negative internal pressure the positiveexterior atmospheric pressure will collapse the sleeve.

In all other respects, the balloon dilatation catheter 26b can beutilized in the same manner as the balloon dilatation cathetershereinbefore described in connection with exchanges on the guide wire27.

Still another embodiment of an angioplasty apparatus incorporating thepresent invention is shown in FIG. 10 in which there is disclosed adedicated pressure/dye catheter 61. The pressure/dye catheter 61consists of an elongate flexible tubular member 62 formed of a suitablematerial such as plastic which is provided with a pressure dye lumen 63extending therethrough. The proximal extremity of the tubular member 62is provided with a Luer-type fitting 64 to which devices havingLuer-type fittings can be attached. A sleeve 66 formed of a suitablematerial such as plastic is secured to the exterior of the flexibletubular member 62 by suitable means such as an adhesive. It is providedwith a guide wire lumen 67 extending therethrough. It should beappreciated that the sleeve 66 can be formed integral with the flexibletubular member 62 if desired. The sleeve 66 extends for a distance of atleast 10 to 15 centimeters from the distal extremity of the catheter 61so that the transition region where it terminates at its proximalextremity is be within the guiding catheter 17 so that the transitionregion does not enter into the arterial vessel of the patient. A guidewire 68 is provided which extends through the guide wire lumen 67. Theguide wire 68 can be of the same type as the guide wire 27. It isinserted into the sleeve 66 by taking the proximal extremity of theguide wire which is relatively stiff and inserting it into the distalextremity of the sleeve and then pushing it backwardly or rearwardlythrough the sleeve until it clears the opening 69 at the proximalextremity of the sleeve 66. The guide wire 68 is then pulled so that itextends in a direction parallel to the flexible tubular member 62 into aregion near the proximal extremity of the tubular member 62.

It can be readily seen from the foregoing description that thepressure/dye catheter 61 can be readily introduced into a guidingcatheter 17 and that the distal extremity of the pressure/dye cathetercan be positioned in a desired location in the arterial vessel byutilizing the guide wire 68 to position the same. It also should beappreciated that a torquer of the type hereinbefore described such asthe torquer 46 can be utilized on the proximal extremity of the guidewire 68 to cause rotational movement of the guide wire to facilitatepositioning of the guide wire in the desired arterial vessel and tothereafter have the tubular member 62 follow the same. The desiredpicture and/or dye measurements can then be made by utilizing the lumen63 provided in the tubular member 62. As can be seen from FIG. 10 thedistal extremity of the tubular member 62 can be slanted and rounded asshown to facilitate entry into the stenosis in the arterial vessel. Thisis desirable because of the eccentricity created by the addition of thesleeve 66.

Another embodiment of an angioplasty apparatus is shown in FIG. 11 andtakes the form of a fiber optic device 71. An encased fiber optic bundle72 which is generally circular in cross section is provided. A sleeve 73of the type hereinbefore described formed of a suitable material such asplastic is secured to the distal extremity of the fiber optic bundle 72which is adapted to receive a guide wire 74. As in the previousembodiments, the sleeve 73 extends from the distal extremity for adistance of approximately 10 to 15 centimeters after which the guidewire exits from the sleeve and extends alongside and exteriorally of thefiber optic bundle 72 for substantially the entire length of the fiberoptic bundle. As with the previous devices, the guide wire 74 isthreaded into the sleeve by taking the proximal extremity or stiff endof the guide wire and inserting it at the distal extremity of the sleeve73 and pushing it from the rear towards the forward extremity of thesleeve. The fiber optic device 71 can then be inserted into a guidingcatheter 17 and advanced to the desired location through the use of theguide wire. The fiber optic bundle then can be utilized for angioscopyfor looking directly at the blood vessel or alternatively, fordelivering energy to plaque in the blood vessel to perform laserangioplasty. It should be appreciated that steerable systems can beutilized for directing the distal extremity of the fiber optic bundle ifthat is desired.

It should be appreciated that the concept of using a relatively shortsleeve extending from the distal extremity of the device to a regionapproximately 10 to 15 centimeters to the rear and then having the guidewire extend externally of the device is applicable for a number ofmedical devices as well as other applications. For example, ultrasoniccatheters for imaging ultrasound and for measurement of Doppler velocitycan be utilized to provide various types of dedicated devices having theguide sleeve with the guide wire therein for facilitating positioning ofthe same in arterial vessels. The apparatus of the present invention isparticularly useful in devices where multiple re-entries are required inorder to complete the procedure.

In FIG. 12, there is disclosed another embodiment of an angioplastyapparatus to provide a pressure dye catheter 76 having additionalsteering capabilities. It consists of a flexible tubular member 77formed of a suitable material such as plastic which is provided with alumen 78 extending through a slanted and curved end. A Luer-type fitting79 is provided on the proximal extremity. A sleeve 81 formed of asuitable material such as plastic is secured to the distal extremity ofthe flexible elongate member 77. The sleeve is provided with a curvedportion 81a which extends slightly beyond the distal extremity of theflexible elongate member 77 and curves over the end of the flexibleelongate member 77. The guide wire 82 extends through the sleeve 81 asshown. The catheter shown in FIG. 12 can be utilized in situations wherethere is an acute bend in the arterial vessel. By using the cathetershown in FIG. 11, the guide wire can be directed into the acute bend byrotation of the catheter 76 to help direct the guide wire into the acutebend. After the acute bend has been negotiated by the guide wire, thedistal extremity of the catheter can follow the guide wire and negotiatethe acute bend. The desired pressure and/or dye measurements can then bemade. If by chance a guide wire should enter the wrong vessel, the guidewire can be retracted into the sleeve and then the catheter itself canbe reoriented to have the distal extremity of the sleeve 81 directedinto the proper region so that the guide wire will enter the properarterial vessel. The catheter 76 shown in FIG. 12 can be introduced intothe guiding catheter 17 in the same manner as the other cathetershereinbefore described.

Still another embodiment of the angioplasty apparatus of the presentinvention is shown in FIG. 13 in the form of a bailout catheter 86. Thebailout catheter 86 consists of a flexible tubular member 87 formed of asuitable material such as plastic which is provided with a lumen 88extending therethrough. A Luer-type fitting 89 is secured to theproximal extremity of the tubular member 87. The distal portion of thetubular member 87 is provided with two sets 91 and 92 of holes 93 whichare spaced circumferentially and apart longitudinally of the tubularmember. A sleeve 96 formed of a suitable material such as plastic issecured to the distal extremity of the tubular member 87 and extendsfrom the distal extremity of the tubular member 87 into a region 10 to15 centimeters from the distal extremity and is adapted to receive aguide wire 97 which extends through the same. The guide wire 97 isinserted into the sleeve by taking the proximal extremity of the guidewire and inserting it into the distal extremity of the sleeve andpushing it rearwardly into the sleeve until it exits from the sleeve.The guide wire 97 is then pulled in a direction generally parallel tothe flexible tubular member 87 until it is adjacent the fitting 89.

The bailout catheter 86 is utilized in situations where an obstructionhas occurred in a blood vessel and stops the flow of blood. In order toreestablish the flow of blood, the bailout device is inserted into theguiding catheter 17. If a guide wire is already in place, the bailoutdevice can be placed on the guide wire by introducing the proximalextremity, of the guide wire into the sleeve and then pushing thebailout catheter on the guide wire into the guiding catheter 17 until itpasses through the obstruction in the arterial vessel. The distalextremity of the bailout device is so positioned so that the obstructionis disposed between the two sets of holes 91 and 92. When the bailoutcatheter is positioned, blood can still flow through the holes 93 pastthe obstruction which is held out of the way by the bailout catheter.

Thus it can be seen that the same principle utilizing a guide tube andan external guide wire passing through the guide tube can be utilizedfor positioning the bailout device. As pointed out previously, thebailout device can be utilized for positioning other types of devices inarterial vessel, as for example, atherectomy devices particularly wheremultiple re-entries or reintroductions of the devices are required.

In FIG. 14 there is disclosed additional angioplasty apparatus in whicha holder 101 is provided which serves as a support structure for ay-type connector 19 of the type hereinbefore described in conjunctionwith the angioplasty apparatus shown in FIG. 1. The holder 101 consistsof a rectangular member 102 which is generally planar. The member 102can be formed of a suitable material such as plastic and is providedwith a plurality of rectangular openings 103 extending longitudinally ofthe same to lighten the same. Posts 104 are provided on the forwardextremity of the member 102 and are adapted to receive the y-typeconnector 19 and to hold it in place on the member 102. When positionedin the posts 104, the knurled knob 21 extends into one of the openings103 so that it can be readily operated. A block 107 is carried by theother end of the member 102 and, if desired, can be formed intergaltherewith. The block is provided with a plurality of spaced apart slots108 which are adapted to frictionally engage and receive the guide wire27. The friction block 107 should be positioned a suitable distance as,for example, 15 to 20 centimeters from the o-ring carried by they-connector 19.

Use of the holder 101 shown in FIG. 14 may now be briefly described asfollows. The holder 101 can be placed on the operating table near theregion where the guiding catheter 17 has been inserted into the patient,as for example, in a femoral artery in the leg of a patient. After theguide wire has been inserted into the guiding catheter, the proximal endor, in other words, the stiff end of the guide wire can, be placed inthe friction clamp 108. When it is desired to utilize a dilatationcatheter, the end of the guide wire which has been positioned in theclamp can be lifted out of the slot 108 and inserted into the sleevecarried by the distal extremity of the dilatation catheter by taking theproximal end and advancing it from the tip rearwardly through thesleeve. As soon as the guide wire has been introduced through thesleeve, the proximal extremity of the guide wire can be repositioned inthe slot 108. Thereafter, the dilatation catheter can be advancedindependently without the operator needing to pay any attention to theguide wire which is held in the desired position by the holder 101.Similarly, the holder can be utilized to keep the guide wire in placewhile the dilatation cathether is being briskly withdrawn.

More than one of the slots 108 has been provided in the holder 101 inorder to make it possible to accommodate two wire or two balloondilatation catheters in which one of the other slots 108 can be utilizedfor accommodating the additional guide wire. This prevents the guidewires from becoming entangled with each other.

It is apparent from the foregoing that there has been provided anangioplasty apparatus which greatly facilitates the exchange of deviceswhich utilize flexible elongate elements as a part thereof. Rapidexchanges are possible with only one person being necessary to make theexchanges. The need for long exchange wires has been eliminated. Onedevice can be readily substituted for another utilizing the same guidewire which has already been positioned. It can be seen from theforegoing that a relatively simple and expedient solution has beenprovided which eliminates the need for long exchange wires and thedanger of those exchange wires becoming contaminated.

Although the present invention has been described principally inconjunction with catheters having coaxial lumens, it should beappreciated that the invention is as applicable, if not more applicable,to catheters having side-by-side lumens.

What is claimed is:
 1. A method for performing an intravascularprocedure at a desired location within a patient's artery, comprising:a)providing within the patient's vasculature a guiding catheter having aproximal end, a distal end, a port in the distal end and an inner lumenextending therein to the port in the distal end with the proximal end ofthe guiding catheter extending out of the patient and the distal end ofthe guiding catheter being located proximal to the location where theintravascular procedure is to be performed; b) providing within thepatient's vasculature an elongated guidewire being slidably disposedwithin the inner lumen of the guiding catheter and having a flexibledistal section extending out the distal end of the guiding catheter andbeyond the desired location where the intravascular procedure is to beperformed and a proximal portion which extends out of the proximal endof the guiding catheter; c) providing an intravascular cathetercomprising:an elongated shaft which has proximal and distal ends, whichis configured for percutaneous introduction into the patient'svasculature and which has a guidewire receiving lumen extending to thedistal end of the shaft, a distal guidewire opening in the distal end ofthe catheter shaft in fluid communication with the guidewire receivinglumen, a proximal guidewire opening spaced a relatively short distanceproximally from the distal end and a relatively long distance from theproximal end of the catheter shaft in fluid communication with theguidewire receiving inner lumen, and means to perform an intravascularprocedure which is disposed on a distal section of the catheter shaftbetween the proximal and distal guidewire openings, which is configuredto perform said procedure in a patient's artery and which is spacedcloser to the distal guidewire opening than the proximal guidewireopening, d) mounting the intravascular catheter onto the proximal end ofthe guidewire which extends out of the proximal end of the guidingcatheter with the proximal portion of the guidewire being slidablydisposed within the guidewire receiving lumen of the intravascularcatheter and extending out the proximal guidewire opening; e)introducing the intravascular catheter into the patient's vasculatureover the guidewire, while holding a portion of the guidewire whichextends out of the proximal guidewire opening in position and advancingthe catheter therein until the means to perform an intravascularprocedure is positioned within the desired location within the patient'sartery, with the distal guidewire opening being distal to the desiredlocation within the patient where the procedure is to be performed andthe proximal guidewire opening being within the inner lumen of theguiding catheter proximal to the desired location; f) performing anintravascular procedure at the desired location within the artery bysaid means; and g) withdrawing the intravascular catheter from thepatient.
 2. A method for performing a balloon dilatation angioplastyprocedure at a desired location within a human patient's coronaryartery, comprising:a) providing an elongated guidewire within thepatient's vasculature having a flexible distal portion of the guidewireextending distal to the desired location therein for performing aballoon dilatation angioplasty procedure and with a proximal portionwhich extends out of the patient; b) providing a balloon dilatationcatheter comprising:an elongated catheter shaft having proximal anddistal ends, an inflation lumen and a guidewire receiving lumen andbeing configured for percutaneous introduction into the patient'sarterial system, a distal guidewire opening in the distal end of thecatheter shaft in fluid communication with the guidewire receivinglumen, a proximal guidewire opening spaced a relatively short distanceproximally from the distal guidewire opening and a relatively longdistance from the proximal end of the catheter shaft in fluidcommunication with the guidewire receiving inner lumen, and a dilatationballoon on a distal portion of the catheter shaft which has an interiorin fluid communication with the inflation lumen extending within theshaft and which is spaced closer to the distal guidewire opening thanthe proximal guidewire opening; c) mounting the balloon dilatationcatheter onto the proximal portion of the guidewire which extends out ofthe patient with the proximal portion of the guidewire being slidablydisposed within the guidewire receiving lumen of the intravascularcatheter and extending out the proximal guidewire opening; d)percutaneously introducing the balloon dilatation catheter into thepatient's arterial system over the guidewire and, while holding aportion of the guidewire which extends out of the proximal guidewireopening in position, advancing the catheter therein until the dilatationballoon is positioned within the desired location within the patient'scoronary artery, with the distal port being distal to the desiredlocation and the proximal port being within the patient proximal to thedesired location; e) inflating the dilatation balloon at the desiredlocation within the coronary artery to perform the balloon dilatationangioplasty procedure; d) deflating the dilatation balloon; and g)withdrawing the balloon dilatation catheter from the patient.